DIN Standards Committee Health Technologies
Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
Abstract
This document specifies information to be supplied to users and third-party verifiers in addition to the usual labelling of medical devices (see EN ISO 20417 and EN ISO 15223 1) concerning manufacturing and processing requirements. This document gives information on the characteristics of single-use and reusable surgical gowns and surgical drapes used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures. This document specifies test methods for evaluating the identified characteristics of surgical drapes and gowns and sets performance requirements for these products. This document does not include information on resistance to penetration by laser radiation of products. NOTE If resistance to penetration by laser radiation is claimed for surgical drapes, suitable test methods together with an appropriate classification system are given in EN ISO 11810. This document does not cover requirements for incision drapes or films. This document does not cover requirements for antimicrobial treatments for surgical gowns and drapes. Antimicrobial treatment can cause environmental risks such as resistance and pollution. However, antimicrobial treated surgical gowns and drapes fall under the scope of this document with respect to their use as surgical gowns and drapes.
Begin
2022-01-21
WI
00205382
Planned document number
FprEN 13795-1
Responsible national committee
NA 176-04-07 AA - Surgical textiles
Responsible european committee
CEN/TC 205/WG 14 - Surgical clothing and drapes, and medical face masks
draft standard
Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
2023-08
Order from DIN Media
previous edition(s)
Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
2019-04
